NCT00370734

Brief Summary

In active phase of thyroid eye disease some patients have obvious upper lid retraction , and sometimes exposure keratopathy .To date there is not any standard treatment for this situation . We are going to compare the natural course of the upper lid retraction with injection of botulinum toxin A injection to upper lid percutaneously.

Trial Health

43
At Risk

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Trial has exceeded expected completion date
Enrollment
50

participants targeted

Target at P25-P50 for phase_2

Timeline
Completed

Started May 2005

Geographic Reach
1 country

1 active site

Status
unknown

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

May 1, 2005

Completed
1.3 years until next milestone

First Submitted

Initial submission to the registry

August 31, 2006

Completed
1 day until next milestone

First Posted

Study publicly available on registry

September 1, 2006

Completed
5 months until next milestone

Study Completion

Last participant's last visit for all outcomes

February 1, 2007

Completed
Last Updated

February 27, 2007

Status Verified

February 1, 2007

First QC Date

August 31, 2006

Last Update Submit

February 26, 2007

Conditions

Eye Diseases

Keywords

botulinum toxinthyroid eye diseaselid retraction

Interventions

Botulinum toxin A injectionDRUG

Eligibility Criteria

Sexall
Healthy VolunteersNo
Age GroupsChild (0-17), Adult (18-64), Older Adult (65+)

You may qualify if:

  • all the patients wiht oper lid retraction in active phase of thyroid ophthalmopathy

You may not qualify if:

  • patients in non active phase

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Babak Babsharif, MD

Tehran, Tehran Province, 16666, Iran

RECRUITING

MeSH Terms

Conditions

Eye DiseasesGraves Ophthalmopathy

Interventions

Botulinum Toxins, Type A

Condition Hierarchy (Ancestors)

Eye Diseases, HereditaryGraves DiseaseExophthalmosOrbital DiseasesGenetic Diseases, InbornCongenital, Hereditary, and Neonatal Diseases and AbnormalitiesGoiterThyroid DiseasesEndocrine System DiseasesHyperthyroidismAutoimmune DiseasesImmune System Diseases

Intervention Hierarchy (Ancestors)

Botulinum ToxinsMetalloendopeptidasesEndopeptidasesPeptide HydrolasesHydrolasesEnzymesEnzymes and CoenzymesMetalloproteasesBacterial ProteinsProteinsAmino Acids, Peptides, and ProteinsBacterial ToxinsToxins, BiologicalBiological Factors

Study Officials

  • Babak Babsharif, MD

    Ophthalmic Research Center of Shaheed Beheshti Medical University

    PRINCIPAL INVESTIGATOR

Central Study Contacts

Babak Babsharif, MD

CONTACT

+98 21 22585952labbafi@hotmail.com

Study Design

Study Type
interventional
Phase
phase 2
Allocation
NON RANDOMIZED
Masking
NONE
Purpose
TREATMENT
Intervention Model
SINGLE GROUP
Sponsor Type
OTHER

Study Record Dates

First Submitted

August 31, 2006

First Posted

September 1, 2006

Study Start

May 1, 2005

Study Completion

February 1, 2007

Last Updated

February 27, 2007

Record last verified: 2007-02

Locations

IR(1)